Risk evaluation tool for chemical contaminants in …...Risk evaluation tool for chemical...
Transcript of Risk evaluation tool for chemical contaminants in …...Risk evaluation tool for chemical...
Risk evaluation tool for chemical contaminants in
the context of RASFF
Ana Afonso
SCER Unit – RASFF contact point
72nd Advisory Forum meeting
Reykjavik, Iceland, 03-04.07.2019
RASFF
▪ Develop a tool to harmonise risk evaluation
▪ Propose methodology for a risk-based classification of RASFF notifications on contaminants
▪ Based on science but practical
▪ Application areas (examples):
➢Industrial and environmental contaminants
➢Heavy metals
➢Mycotoxins and other biotoxins
➢Migration from food contact materials
➢Residues of pharmacologically active substances
Mandate to EFSA3
▪EFSA staff (SCER, DATA, CONTAM, FIP) and external experts
▪3 Work Packages (WP):
➢WP1 Toxicological parameters
➢WP2 Estimating exposure
➢WP3 IT tool
▪Consultation with RASFF network
EFSA working group
4
https://efsa.onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2019.EN-1625
TECHNICAL REPORT
5
WP1 Toxicological parameters
▪EU legislation
▪ Past notifications - RASFF database
▪EFSA Scientific publications*:
➢ Contaminants in food and feed
➢ Substances which are both genotoxic and carcinogenic
➢ Margin of Exposure (MoE) approach
➢ Threshold of Toxicological Concern (TTC)
➢ Reference Points for Action (RPAs)
➢ etc.
▪Peer-reviewed publications**Note: full name of publications in Annex
Methodology
7
▪ Identification of potential genotoxic and carcinogenic properties of the contaminant
▪Available HBGV (ARfD, TDI, TWI, TMI, etc)
▪Available Reference Point (NOAEL, BMDL)
▪Use of the Threshold of Toxicological Concern (TTC) approach
▪Exposure assessment
▪Output
Decision tree principles
WP2 Estimating exposure
▪Collected from EU Member States
▪Stored in the EFSA Comprehensive European Food Consumption Database
Food consumption data
10
FoodEx2
Webinar: The FoodEx2 classification system
➢A common language
➢Developed and maintained by EFSA
➢Clearly defined groups
➢Parent-child structure
11
WP3 IT tool
Overview
Example: 100 μg/kg TTX (tetrodotoxin) in mussels
13
FoodEx2:
Trigger: analytical result showing
potential concern or exceedance of legal
limits
0. Is the compound genotoxic and carcinogenic?
No
1. Is there an ARfD
available?
Yes8. Exposure assessment
Is exposure > HBGV
EFSA, 2017: ARfD 0.25 µg/kg bw
IT tool: summary outcome*
*values are example only
Considerations in characterising the risk
No risk;
Low probability of adverse health effects;
Low concern for public health
No risk
Outcome of the Decision Tree
RASFF terminology
Serious risk
Risk / Potential risk Not serious risk
Rate of exceedance;
Population categories exposed;
Severity of the effect;
Duration of exposure;
Characteristics of the food
14
➢ Not risk assessment (time /data requirements)
➢ Τransparent evaluation
➢ Accept uncertainty
In summary15
Analyticalresults
Use of the tool
OUTCOME
▪Tool access https://www.efsa.europa.eu/en/microstrategy/race
▪Tool manual => Appendix J
▪Tool registration
▪Technical support by EFSA
▪ Feedback from RASFF network
▪ Future developments
Final Notes
Stay connected
www.efsa.europa.eu/en/engage/careers
www.efsa.europa.eu/en/rss
Subscribe to
Engage with careers
Follow us on Twitter@efsa_eu@plants_efsa@methods_efsa
www.efsa.europa.eu/en/news/newsletters
18
19
Annex
Non-genotoxic, non carcinogenic substances 1/2
20
Trigger: analytical result showing potential
concern or exceedance of legal limits
0. Is the compound genotoxic and carcinogenic?
Yes
See following slide; questions 1G-3G
No
2. Is there a TDI, TWI, TMI or other chronic HBGV
available?
Yes
NoSee following slide;
questions 3-7
*depending also on rate of exceedance, food, population category/ies exposed etc. Note: draft decision tree for food contaminants and food contact materials
No1. Is there an
ARfDavailable?
Yes No
Yes
8. Exposure assessment
Is exposure > HBGV
No Risk
Risk / Potential risk*
If chronic exposure should be considered
as well
Non-genotoxic and non carcinogenic substances 2/2
21
No
No5. Exposure assessment
Is exposure > 1.5 mcg/Kg bw per day#
Low probability of adverse health
effects
*depending also on rate of exceedance, food, population category/ies exposed etc. ‡margin to be defined; # for organophosphates and carbamates the threshold is 0.3 mcg/kg b.w. per day
2. Is there a TDI, TWI, TMI or other chronic
HBGV available?
Yes
No3. Is there a RP available
(e.g. BMDL, NOAEL)?
4. Exposure assessmentIs RP / exposure
> 100 x (1 to 10)‡
Low concern for public health
No
Yes
Risk / Potential risk*
Yes
6a. Substance in Cramer Class II or III
Yes
6b. Substance in Cramer Class I
Yes No
7. Exposure assessmentIs exposure >
30 mcg/Kg bw per day
No
Genotoxic and carcinogenic substances
22
0. Is the compound genotoxic and carcinogenic?
No
See previous slides; questions 1-8
No
No3G. Exposure assessment
Is exposure > 0.0025mcg/Kg bw per day
Low probability of adverse health
effects
Yes
*depending also on rate of exceedance, food, population category/ies exposed etc. **In the absence of BMDL, if T25 is available then a margin of 25,000 shall be considered.
Note: draft decision tree for food contaminants and food contact materials
Low concern for public health
Yes1G. Is there a
RP (e.g. BMDL) available?
Yes2G. Exposure assessment
Is BMDL10 / exposure> 10,000? **
Risk / Potential risk*
No
Yes
Example:50 µg/kg beauvericin (BEA) in dried pasta
23
FoodEx2: IT tool: summary outcome*
*values are example only
No HBGV or RP are available
0. Genotoxic/ carcinogenic?
No5. Exposure assessment
Is exposure > 1.5 mcg/Kg bw per day
No3. Is there a RP available (e.g.
BMDL, NOAEL)?1-2. HBGV?No
Example: 127.63 µg/kg PAH4 in dried garlic
0. Is the compound genotoxic and carcinogenic?
Yes Yes
2G. Exposure assessmentIs BMDL10 / exposure
> 10,000?
1G. Is there a RP (e.g. BMDL)
available?
EFSA, 2008: BMDL10 340 µg/kg bw/day
FoodEx2:
*values are example only
IT tool: summary outcome*
Example: 47 μg/kg ochratoxin (OTA) in dried mulberries
0. Is the compound genotoxic and carcinogenic?
1. ARfD?
No
2. Is there a TWI
available?
Yes8. Exposure assessment
Is exposure > HBGV
EFSA, 2006: TWI 120 ng/kg bw
FoodEx2:
*values are example only
IT tool: summary outcome*
MAIN REFERENCES
26
EFSA Scientific outputs
▪ Opinion of the Scientific Committee on a request from EFSA related to a harmonised approach for risk assessment of substances which are both Genotoxic and Carcinogenic. EFSA Scientific Committee, 2005 ; DOI: 10.2903/j.efsa.2005.282
▪ Statement on the applicability of the Margin of Exposure approach for the safety assessment of impurities which are both genotoxic and carcinogenic in substances added to food/feed- EFSA Scientific Committee, 2012; DOI: 10.2903/j.efsa.2012.2578
▪ EFSA Scientific Committee, 2012. Scientific opinion on exploring options for providing advice about possible human health risks based on the concept of Threshold of Toxicological Concern (TTC) - DOI: 10.2903/j.efsa.2012.2750
▪ Alexander J, Benford D, Boobis A, Eskola M, Fink-Gremmels J, Fürst P, Heppner C, Schlatter J, van Leeuwen R; Special Issue: Risk assessment of contaminants in food and feed. EFSA Journal 2012;10(10):s1004. [12 pp.]. doi:10.2903/j.efsa.2012.s1004.
▪ Risk assessment of contaminants in food and feed, EFSA CONTAM, 2012 ; DOI:10.2903/j.efsa.2012.s1004
▪ EFSA CONTAM Panel, 2013. Guidance on methodological principles and scientific methods to be taken into account when establishing Reference Points for Action (RPAs) for non-allowed pharmacologically active substances present in food of animal origin. EFSA Journal 2013;11(4):3195, 24 pp.
Peer-reviewed publications
▪ Benford D. et al. Application of the Margin of Exposure (MOE) approach to substances in food that are genotoxic and carcinogenic, Food and Chemical Toxicology 48(2-24), 2010.
▪ Kroes R. et al. Structure-based thresholds of toxicological concern (TTC): guidance for application to substances present at low levels in the diet, Food and Chemical Toxicology 42(65-83), 2004.
Stay connected
www.efsa.europa.eu/en/engage/careers
www.efsa.europa.eu/en/rss
Subscribe to
Engage with careers
Follow us on Twitter@efsa_eu@plants_efsa@methods_efsa
www.efsa.europa.eu/en/news/newsletters